GUEST CONTRIBUTORS

  • 5 Best Practices Merck Used To Implement Strategic Sourcing Partnerships
    5 Best Practices Merck Used To Implement Strategic Sourcing Partnerships

    In order to effectively extend the capacity of its organization using external partners, Merck & Co., Inc. decided to shift from limited, tactical, piecemeal outsourcing to a strategic outsourcing model. This article summarizes the first five of 10 key elements — or best practices — that were critical for the successful implementation of its strategic partnerships.

  • Will CDMOs Commit To Fully Transparent Audits?
    Will CDMOs Commit To Fully Transparent Audits?

    The first two articles in this series discussed the physical elements of facility design that sponsors look for in their contract development and manufacturing organizations (CDMOs) and sponsor requirements for dedicating equipment to GMP operations, equipment redundancy, and immediate disclosure of equipment and facility issues. This article presents solutions to improve transparency during sponsor audits of CDMOs.

  • Key Takeaways From The FDA’s New Continuous Manufacturing Guidance
    Key Takeaways From The FDA’s New Continuous Manufacturing Guidance

    The FDA recently issued a draft guidance entitled “Quality Considerations for Continuous Manufacturing” in an effort to advance greater predictability for companies adopting CM technology. Specifically, the FDA hopes this draft guidance will support the development and adoption of CM for brand, generic, and over-the-counter drugs.

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PHARMA OUTSOURCING WHITE PAPERS

BsAbs: Save Time With One-Step Purification BsAbs: Save Time With One-Step Purification

Bispecific antibodies (BsAb) can, in early screening phases, be purified using protein A chromatography in a single step. In this study, BsAb constructs were efficiently purified using a one-step approach, saving 4 to 6 weeks.

What Clinical Teams Should Know About Changing Trial Logistics What Clinical Teams Should Know About Changing Trial Logistics

When it comes to clinical supplies, the journey is every bit as important as the destination and the price of failure is high. This paper discusses how supply logistics are changing and contains examples of how Fisher Clinical Services is deploying flexible solutions to ensure secure, efficient and cost-effective passage of clinical supplies.

A Sleeping Giant No More: Opportunities & Challenges For Clinical Research In China

This paper examines the opportunities and challenges of conducting clinical trials in China, and offers proven strategies for overcoming hurdles.

Efficient Cleaning-In-Place Methods For Protein-Based Antibody Affinity Chromatography Resins

This whitepaper discusses cleaning of affinity resins intended for use in the purification of monoclonal antibodies and antibody fragments.

Unlocking The Potential For Efficiency In Downstream Bioprocesses

In the bioprocessing industry, in order to make full use of upstream advances in an efficient manner, it is essential that downstream processes are intensified.

Choosing The Best Sterile Dosage Form For Your Phase 1 Needs

When developing a parenteral product, pharmaceutical scientists are faced with a variety of choices — choices that can be conflicting or present differing advantages.

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PHARMA OUTSOURCING APP NOTES & CASE STUDIES

Manufacturing Of Sterile Aqueous Suspensions: A Primer

Sterile suspensions are particularly difficult to manufacture. This technical article covers factors for success, including particle size, vehicle formulation, and considerations for high-shear mixing. 

Best Practices In Supply Chain Management: A CMO Perspective

Supply chain management has advanced rapidly over the past decade, evolving from what was once dubbed “materials management” into the essential glue that binds all aspects of a business’ internal and external collaborations.

Data Driven Market Success
A Quintiles customer needed an experienced post-marketing ally who could plan for the unknown and design an observational study to eventually include several affiliates, thousands of sites, and more than 55,000 patients, with start-ups staggered over time.
Estimating The Budget Impact Of A New Pain Treatment

Opioids are used to treat both acute and chronic pain; however, traditional μ-opioids are often associated with opioid-induced side effects that can limit treatment effectiveness. Issues with tolerability have led to the development of novel opioids that may have a more favorable adverse event profile.

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ABOUT US

Outsourced Pharma provides comprehensive analysis and exclusive content from thought leaders for the advancement of global outsourcing of drug development and manufacturing. We offer readers of our website and participants of our conferences – our Outsourced Pharma community – a deeper exploration and understanding of the relationships between pharmaceutical and biotechnology organizations with their service providers, and an open channel of communication.

About Outsourced Pharma Conferences
Outsourced Pharma Conference & Exhibition is a vibrant forum for thought-leadership and the application of best practices for professionals engaged in outsourcing drug development and manufacturing. These conferences and exhibitions form a community for networking and discussing topics most relevant to sponsor-provider partnerships and supply-chain management, within an open format that promotes panel and attendee interaction.

About OutsourcedPharma.com
OutsourcedPharma.com provides comprehensive analysis of global outsourcing, the biotechnology and pharmaceutical industries, and their intersection with the overall life sciences and healthcare markets. We offer readers a deeper exploration and understanding of the relationships between service providers and their bio and pharma sponsors.

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